RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.
|Articles|September 25, 2019
SCDM Releases Trends Impacting Clinical Data Management
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The Society for Clinical Data Management, SCDM, has released its latest Reflection Paper, “The Evolution of Clinical Data Management to Data Science.” Patrick Nadolny, Chair of the SCDM Innovation Committee and Global Head of Clinical Data Management and Programming at Allergan noted the goal of the paper is to provide a “forward-looking and pragmatic view on why and how emerging study designs, regulations, and technology innovations are reshaping the role and profile of clinical data management. ”
Highlights include: [Link to paper
- The impact of the rising complexity of clinical research approaches such as adaptive study design and decentralized clinical trials
- What a continually shifting regulatory environment means for data quality and clinical data management practices, including definitions of data quality and riskâbased clinical data management.
- How new technologies such as Artificial Intelligence (AI) and wearable are transforming clinical trials leading to the reduction of electronic data capture (EDC) centricity moving forward
- Career considerations for clinical data managers – among them how the role of the clinical data manager is changing, why clinical data management is at the heart of riskâbased study execution, and new skillsets necessary for managing the evolution of clinical data.
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